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NCT07405151PHASE1, PHASE2Recruiting

A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)

Merck Sharp & Dohme LLC

Start Date

3/27/2026

Completion Date

6/12/2028

Summary

The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.

Detailed Description

The master screening protocol is MK-3475-U06 (KEYMAKER-U06)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) * Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC * Has measurable disease * If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy * Has adequate organ function Exclusion Criteria: * Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype * Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention * Has clinically significant corneal disease * Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event * If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has uncontrolled or significant cardiovascular disease * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system metastases and/or carcinomatous meningitis * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Has active infection requiring systemic therapy other than those permitted. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen

Interventions

BIOLOGICAL

I-DXd

DRUG

Rescue Medication

Interested in This Trial?

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Conditions

Oesophageal Squamous Cell Carcinoma

Locations

UPMC Hillman Cancer Center ( Site 3904)

Pittsburgh, Pennsylvania 15232

United States

Liga Norte Riograndense Contra o Cancer ( Site 3301)

Natal, Rio Grande do Norte 59062-000

Brazil

Beijing Cancer Hospital ( Site 2500)

Beijing, Beijing Municipality 100142

China

Jinan Central Hospital ( Site 2507)

Jinan, Shandong 250000

China

Masarykuv onkologicky ustav ( Site 4000)

Brno, Brno-mesto 565 53

Czechia

Aichi Cancer Center ( Site 2702)

Nagoya, Aichi-ken 464-8681

Japan

Kanagawa Cancer Center ( Site 2701)

Yokohama, Kanagawa 241-8515

Japan

National Cancer Center Hospital ( Site 2700)

Chūō, Tokyo 104-0045

Japan

Oslo universitetssykehus, Radiumhospitalet ( Site 3501)

Oslo, 0379

Norway

National Cancer Center ( Site 2902)

Goyang-si, Kyonggi-do 10408

South Korea

Asan Medical Center ( Site 2901)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 2900)

Seoul, 06351

South Korea

Kantonsspital Graubünden-Medizin ( Site 3700)

Chur, Kanton Graubünden 7000

Switzerland

Hopitaux Universitaires de Geneve HUG ( Site 3701)

Geneva, 1211

Switzerland

Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)

Kaohsiung City, 83301

Taiwan

China Medical University Hospital ( Site 3007)

Taichung, 40447

Taiwan

National Cheng Kung University Hospital ( Site 3001)

Tainan, 704

Taiwan

National Taiwan University Hospital ( Site 3000)

Taipei, 10002

Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 3010)

Taipei, 106

Taiwan

Taipei Veterans General Hospital ( Site 3005)

Taipei, 11217

Taiwan

Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)

Taoyuan, 33305

Taiwan

Faculty of Medicine Siriraj Hospital ( Site 3102)

Bangkoknoi, Bangkok 10700

Thailand

Songklanagarind Hospital ( Site 3101)

Hat Yai, Changwat Songkhla 90110

Thailand